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PMCF Investigation of Medical Device ChitoCare® Medical

PMCF Investigation of Medical Device ChitoCare® Medical

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Phase N/A
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Overview

This is a post-marketing observational clinical investigation conducted as part of the post-market clinical follow-up of ChitoCare® Medical, aimed to confirm safety and efficacy according to the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, for the following indications:

Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne

Spray - conditions after dermatosurgical procedures, dermatitis, acne

Eligibility

The inclusion criteria are fully according to indications:

  • Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne
  • Spray - conditions after dermatosurgical procedures, dermatitis, acne

The criteria for exclusion are fully according to contraindications:

  • Allergy to any of the ingredients of the product

Study details
    Dermatitis
    Acne
    Conditions After Dematosurgical Procedures
    Scars

NCT06850389

Primex ehf

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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